Kornimate/medical-research-clean huggingface dataset:
effect of cfr and iron supplementation on iron status and gut microbiota of 1-2 years old myanmar children

Conditions: Iron Deficiency; Iron Deficiency Anemia

Summary: complementary feeding diet in developing countries cannot meet iron requirements of infants and young children. iron supplementation is mostly used to treat iron deficiency whereas iron fortification is cost-effective strategy to control iron deficiency in developing countries. however, a recent study showed that iron fortification imposed negative impact on gut microbiota by increasing colonization of gut pathogen over beneficial bacteria. gut microbiota plays essential roles in nutrient absorption, vitamin synthesis; intestinal mucosal barrier function and pathogen displacement. iron is essential for growth and virulence of most gut pathogens and so iron supplementation might have similar negative impact on gut microbiota composition. therefore, nutrition interventions would not be justified by assessing micronutrient status alone ignoring any possible deterioration of gut microbiota. the investigators hypothesized that optimizing the nutrient intake from locally available foods according to complementary feeding recommendation (cfr) can improve the iron status of these children while maintaining healthy gut microbiota composition. a randomized, placebo-controlled, community-based, intervention trial will be conducted in ayeyarwady division of myanmar where childhood undernutrition is prevalent. the aim of this study is to compare the effect of optimized cfr to iron supplementation on iron status and gut microbiota composition of 1-2years old myanmar children. cluster randomization will be done at the village level to randomly allocate the villages into cfr or non-cfr villages. individual randomization will be done to randomly assign each child into iron or placebo syrup so that individual children will receive one of 4 treatment groups (cfr, fe, cfr + fe, and control) for a period of 24 weeks. based on expected between-groups difference of hemoglobin 5g/l, at 80% power, 5% level of significance, 15% drop-out rate; after taking into account the cluster effect; required sample will be 109 per group (total = 436). a sub-sample of 15 children from each group will be randomly selected for gut microbiota assessment (total = 60). blood samples for iron status and stool samples for gut microbiota assessment will be collected at baseline and endline. anthropometric measurements, usual intake of iron and infectious disease morbidity will also be assessed.


Eligibility criteria:
inclusion criteria: * age between 12-18 months * apparently healthy * not consuming regular iron containing supplements during the last 4 months exclusion criteria: * with severe anemia (hemoglobin \< 50g/l) * malaria test positive with immuno-chromatographic test (ict) * mothers/ caregivers are not willing to join the study * suffer from chronic diseases which can affect their dietary intake
a lifestyle program on healthy weight in postpartum period

Conditions: Weight Reduction

Summary: the aim of this study is to examine the impact of lifestyle intervention on postpartum weight loss. so the investigators will have two groups in this study. in experimental group women will receive the healthy lifestyle intervention. this intervention will have been delivered during 12 weeks. in control group women will receive general information via pamphlet about postpartum period and tips for stress management.

this study will be conducted in two phases. in the first phase , the investigators will conduct a cross-sectional study to assess factors related to the healthy lifestyle after childbirth based on the precede model. regarding results of the study, the investigators will plan and implement a lifestyle promoting intervention and will evaluate the effect of the intervention on weight reduction among postpartum women.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * lactating * non-smoking * full-term birth * lack of medical problems * lack of any pregnancy-related complications (eg, multiple pregnancy, fetal anomalies, fetal or maternal complications in current or previous pregnancy, and hypertension in pregnancy). * nonparticipation in other studies which may affect the results. * 18.5≤ bmi≤29 before pregnancy * women who are sedentary according to the international physical activity questionnaire. exclusion criteria: * unwilling to continue participation in the study * pregnancy during the study * suffering physical problems during the study * smoking after birth

Keywords: postpartum period
prevention of postoperative nausea and vomiting in patients undergoing vitrectomy under local anesthesia

Conditions: Postoperative Nausea and Vomiting

Summary: vitreoretinal surgery is associated with a considerable incidence of postoperative nausea and vomiting (ponv), which is reported to be as high as 60%. reasons for this high incidence may be the long duration of surgery and anesthesia and the high degree of manipulation of the eye. postoperative vomiting after vitrectomy is an important risk factor for the onset of several complications, such as suprachoroidal hemorrhage, with disastrous visual consequences. to date there is no evidence as to the possible protective effect of anti-emetic therapy with regard to interventions of vitrectomy performed under local anesthesia. in this prospective, randomized, multicenter, double blind study, we evaluated the efficacy of ondansetron alone, dexamethasone alone and in combination in controlling nausea and vomiting in patients undergoing vitrectomy under local anesthesia.

patients were randomly stratified to receive 1 of 4 prophylactic antiemetic treatments (3 pharmaceutical treatment and 1 placebo) in a double-blind manner at the start of the surgery and 15 minutes before the end of surgery. the syringes were prepared by a third, neutral person not involved in the perioperative care of the patient, immediately before the start of anesthesia. all vitrectomy surgeries were performed, in each unit,under local anesthesia by a retrobulbar block. each patients was observed and treated during a period of 24 hours after the surgery. for patients who have nausea and vomiting despite the antiemetic prophylaxis, will be given a rescue dose of 4 mg ondansetron iv.

Eligibility criteria:
inclusion criteria: * age 18 or older with an american society of anesthesiologists (asa) physical status of i to ii * scheduled for vitrectomy under local anesthesia exclusion criteria: * hypersensitivity to study drug or rescue medication * preoperative score for nausea greater than 4 out of 10 points * subjects who suffer from chronic nausea and/or vomiting * severe hepatic insufficiency (child-pugh score \> 9) * other antiemetic within 12 hours prior to surgery * patients unable to undergo a local anesthetic * subjects with clinically significant or unstable cardiac, respiratory, hepatic, renal, or other major organ system disease * psychotic illness or depression * addiction to illicit substances or alcohol * non-psychotic emotional disorders * pregnant or lactating * subjects who, in the opinion of the investigator, would experience an unacceptable risk from administration of study drug

Keywords: ondansetron dexamethasone vitrectomy local anesthesia
risk of stroke in pulmonary embolism with a patent foramen ovale (pfo)

Conditions: Silent Stroke; Pulmonary Embolism; Patent Foramen Ovale

Summary: pulmonary embolism is associated with a small but definite risk of paradoxical embolism in patients with a patent foramen ovale (pfo). while neurologic complications are unfrequent the incidence of clinically silent brain infarction is unknown. we will assess the rate of clinically apparent and silent cerebral embolism in patients with a pulmonary embolism (pe) in relation to the presence or not of a pfo.


Eligibility criteria:
inclusion criteria: * pulmonary embolism, informed consent signed, no-contraindication to mri exclusion criteria: * contra-indication to mri, informed consent not obtained

Keywords: stroke pfo embolism
usage of meropenem/gentamicin versus ceftazidime/avibactam in ards

Conditions: Ventilator Associated Pneumonia

Summary: this was a prospective double blind study conducted on 200 polytrauma patients admitted to king abdul-aziz specialized hospital, taif, ksa between july 2018 and december 2019 in surgical icu. all patients were having severe chest trauma, contused lungs either with or without severe head trauma.

patients of group a received meropenem one gram slowly iv infusion every 8 hours for 14 days and gentamicin 7 milligram (mg)/ kilogram body weight per day slowly iv infusion once daily only for one week, while patients of group b received ceftazidime 2 grams and avibactam 500 mg every 8 hours for 14 days in solution for injection(sodium chloride 9 mg/ml (0.9%), sodium chloride 4.5 mg/ml, dextrose 25 mg/ml, 0.45% sodium chloride, 2.5% dextrose and/or lactated ringer's solution). the solution for injection should be administered over 120 minutes. • temperature was measured every 3 hours for 2 weeks. • abg was done every 8 hours for 2 weeks. • cbc including white cell count was done daily and for 2 weeks. • complete renal functions daily (urea and creatinine serum level) for 2 weeks. any patient showing rise in the creatinine level was recorded and excluded from the study. • chest x-ray for all the patients was ordered after intubation and with onset of ventilation and every 24 hours for 2 weeks. • all patients received anti-stress (omeprazole 20 mg iv every 12 hours). • oro-gastric tubes were inserted to all patients and feeding was started within 24 hours.daily evaluation for conscious level and need for sedation and ventilation were done for all patients. • tracheobronchial lavage was obtained by bronchoscopy 2 times a week and sent for qualitative culture for 2 weeks. • blood culture was also taken 2 times per week for 2 weeks. • the planned duration of the study is two weeks from diagnosis of vap and starting the antibiotics so any patients who failed to be weaned within this period were considered morbidity and recorded.

Eligibility criteria:
inclusion criteria patients with respiratory failure diagnosed by abg,chest xray, and clinical by arterial oxygen low saturation. exclusion criteria: * any other types of respiratory failure rather than trauma
behavioral activation for dementia caregivers

Conditions: Dementia Caregivers

Summary: this project was designed to test a model targeted intervention for dementia caregivers telephone program consisting of both psychoeducation and behavioral activation components to reduce the burden of caregivers. the program is delivered by telephone to increase accessibility and sustainability for caregivers.

the study compared two telephone interventions using a four-month longitudinal randomized controlled trial. for the first four weeks, all participants received the same psychoeducation program via telephone. then for the following four months, eight biweekly telephone follow-up calls were carried out. for these eight follow-up calls, participants were randomized into either one of the two following groups with different conditions. for the psychoeducation with ba (psyed-ba) group, participants would receive eight biweekly sessions of ba practice focused on pleasant event scheduling and improving communications. for the psychoeducation only (psyed only) group, there would be eight biweekly sessions of general discussion of psychoeducation and related information

Eligibility criteria:
inclusion criteria: they were caregivers aged 25 or above and must have be caring for a care recipient diagnosed with alzheimer's disease for at least 3 months. they should be the primary caregiver and a spouse, kin (e.g. daughter/son or daughter/son-in-law) or sibling of the care recipient. exclusion criteria: to ensure intervention fidelity, participants who showed signs of severe intellectual deficits, demonstrate suicidal ideation, exhibit evidence of psychotic disorders, or cannot read or speak fluent chinese / cantonese were excluded.
radiotracer-based perfusion imaging of patients with peripheral arterial disease

Conditions: Peripheral Artery Disease; Diabetes Mellitus; Chronic Limb-Threatening Ischemia

Summary: the aim of this clinical study is to 1) establish a healthy database for nuclear perfusion imaging of the lower extremities and 2) assess the prognostic value of radiotracer-based perfusion imaging for predicting clinical outcomes in patients with peripheral artery disease (pad) who are undergoing lower extremity revascularization procedures. we hypothesize that radiotracer imaging of the lower extremities will provide a sensitive non-invasive imaging tool for quantifying regional abnormalities in skeletal muscle perfusion and evaluating responses to medical treatment.

pad patients (n=80) with peripheral artery disease (pad) who are scheduled to undergo lower extremity revascularization procedures will be recruited. patients will be screened using a standard medical history questionnaire and a physical activity questionnaire. once their questionnaires are reviewed, individuals who meet inclusion criteria will proceed with standard pad screening, which will include ankle-brachial indices (abis) and toe-brachial indices (tbis) of both lower extremities. patients will undergo spect/ct or pet/ct perfusion imaging prior to their revascularization procedure and 1-14 days following revascularization. subjects will receive an intravenous injection of a standard clinical dose of radiotracer for both imaging sessions. a low-dose ct scan will be performed immediately after each spect and pet image acquisition for the purposes of attenuation correction and regional analysis of radiotracer uptake. clinical outcomes will be evaluated for up to 12 months after the imaging study to assess the prognostic value of perfusion imaging for predicting subsequent outcomes. an additional subset of pad patients (n=56) and healthy control subjects (n=56) will be enrolled to undergo the same imaging procedures to establish a healthy database for pet perfusion imaging measures.

Eligibility criteria:
inclusion criteria for patients with peripheral artery disease: 1. at least 18 years of age 2. evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by prior abi, tbi, ct angiography, ultrasound, or mr imaging. exclusion criteria for patients with peripheral artery disease: 1. unable to give informed consent or follow-up 2. pregnant or nursing 3. under the age of 18 4. no history of peripheral artery disease inclusion criteria for healthy control subjects: 1. at least 18 years of age 2. no evidence or prior diagnosis of peripheral artery disease based on chart review and standard vascular screening. exclusion criteria for healthy control subjects: 1. unable to give informed consent of follow-up 2. pregnant or nursing 3. under the age of 18 4. history of peripheral artery disease

Keywords: radionuclide imaging perfusion imaging positron emission tomography single photon emission computed tomography
postoperative analgesia impact of narcotic free anesthesia

Conditions: Pain, Postoperative; Breast Cancer; Postoperative Nausea and Vomiting

Summary: the first hypothesis of the study is that substituting fentanyl by esmolol and metoprolol during general anesthesia for patients undergoing mastectomy will result in less pain and less narcotic consumption in the recovery room. the investigators will also verify the impact of that substitution on nausea and vomiting, on the time spent in the recovery room and on chronic postsurgical pain (3 and 6 months). finally, the investigators will see the impact on breast cancer recurrence 5 years after the surgery.


Eligibility criteria:
inclusion criteria: * woman * 18 to 65 years old * asa 1 or 2 * first breast surgery * unilateral breast cancer * partial mastectomy or radical modified mastectomy ± axillary dissection exclusion criteria: * allergy or contrindication to any medication figuring in the protocol or to aspirin * patient taking betablocking drug drug or lanoxin or calcic channels blocking drug * narcotic consumption in the past month of 10 mg/day of morphine equivalent * chronic pain * moderate to severe asthma * bmi of more than 40 * diabetes * chronic renal or hepatic faiure * heart failure * anticipated difficult airway * high grade heart block or bifascicular block * mental retardation

Keywords: narcotic opioid betablocking drug postoperative pain postoperative nausea and vomiting breast cancer hyperalgesia cancer recurrence anesthesia mastectomy chronic postsurgical pain syndrome acute postoperative pain postmastectomy pain syndrome pain ambulatory surgery
reoperation rate in breast-conserving surgery using confocal histolog® scanner for intraoperative margin assessment

Conditions: Breast Cancer - Ductal Carcinoma in Situ (DCIS); Breast-Conserving Surgery

Summary: this pmpf study is proposed to evaluate in real life the reoperation rates (ror) of breast cancer and/or dcis surgery when including the use of the hls in the context of breast lumpectomy margin assessment.


Eligibility criteria:
inclusion criteria: * adult female subject ≥18 years old. * subject scheduled for breast conserving surgery of invasive and/or in-situ ductal carcinoma. * subject is able to read, understand and sign the informed consent. exclusion criteria: * subject previously treated for ipsilateral breast cancer and/or ductal carcinoma in situ surgery. * subject with previous radiotherapy of the ipsilateral breast. * subject with multicentric/multilateral breast cancer. * subject with planned mastectomy, tumor-adapted breast reduction. * subject with pre-surgical/ preoperative neo-adjuvant treatment. * subject is pregnant/ lactating. * participation in any other clinical study that would affect data acquisition.

Keywords: reoperation rate breast conserving surgery confocal laser scanning microscope confocal microscopy
topical tranexamic acid (txa) in joint arthroplasty

Conditions: Osteoarthritis; Hip Arthropathy; Shoulder Arthropathy

Summary: the objective of this study is to evaluate the efficacy of topical tranexamic acid (txa) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty. txa functions to decrease blood loss by affecting the blood clotting system within the body. the investigators hypothesize that topical application of txa prior to closure reduces postoperative bleeding as measured by absolute changes in postoperative hemoglobin levels and surgical drain output. in addition, use of topically applied tranexamic acid may reduce the need for transfusions, the rates of hematomas, infections, and length of hospital stay.


Eligibility criteria:
inclusion criteria: * shoulders: all adult patients over the age of 18 scheduled for a primary total arthroplasty or a primary reverse shoulder arthroplasty will be eligible for inclusion in the study. hips: all adult patients over the age of 18 scheduled for a primary total hip arthroplasty will be eligible for inclusion in the study. exclusion criteria: * allergy to txa, refusal of blood products, preoperative use of anticoagulant therapy within 5 days of surgery, history of seizures, renal failure (creatine clearance \<30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or pulmonary embolism), significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia), or perioperative anemia (hemoglobin \<11g/dl in females and \< 12g/dl in males).

Keywords: tranexamic acid (txa)
thorax enlarging surgery: a novel surgical approach to emphysema

Conditions: COPD; Emphysema

Summary: there is a growing population of end-stage copd patients for whom surgical treatments like lung transplantation and lung volume reduction surgery are not possible. in such patients, size mismatch between large emphysematous lungs and a restricted chest wall is a major cause for the reduction of dynamic lung volumes and consequent dyspnea. we hypothesized that enlargement of the thorax would be a potential alternative strategy to volume reduction surgery as it may improve lung mechanics by resizing the chest to the lung and does not further deprive patients from lung tissue which is already scarce.

lung volume reduction surgery primarily increases vital capacity by reducing rv more than tlc. as the chest wall is the major tlc limiting factor, an alternative approach that could circumvent size mismatch would be a surgical enlargement of the thorax cavity. any post-operative increase of tlc would allow greater dynamic operational lung volumes to occur with an equal amount of dead space. moreover, resizing of the thorax would have a tremendous advantage over resizing of the lung, in that it would not require resection of the lung in patients in whom lung tissue is already scarce. chest expansion will only be guaranteed if the sternal widening osteotomy will obtain a solid union. small poly-ether-ether-keton (peek) cages were designed to match both sternal halves in a 'press fit' way, which were filled with lyophilised bone and fixed with extra wires as in a classical sternotomy. these bone-filled cages function as a perfect matrix for progressive in-growth of cancellous bone.

Eligibility criteria:
inclusion criteria: patients with end-stage emphysema and * disabling dyspnea * gold iii or iv * residual volume \> 200% predicted * total lung capacity \> 120% predicted * rv/tlc \> 0.6 * resting co2 \< 50 mmhg * diffusion capacity \> 20% predicted * age \< 70 years exclusion criteria: * previous sternotomy * contraindication of general anesthesia * chronic treatment with corticosteroids * any tobacco use within 6 months * candidates for lung volume reduction surgery or lung transplantation

Keywords: copd emphysema thorax enlargement lvrs
mode of action study of vilaprisan and ulipristal acetate in patients with uterine fibroids for whom surgery is planned

Conditions: Leiomyoma

Summary: to investigate the clinical effects of vilaprisan and ulipristal acetate at molecular and cellular level on uterine and fibroid tissue taken from patients (after surgery / biopsy)


Eligibility criteria:
inclusion criteria: * patients 18 years and older and premenopausal (based on gynecological history i.e. still menstruating; no significant estrogen deficiency symptoms) * diagnosis of uterine fibroids documented by ultrasound and relevant symptoms reported by the patient (e.g. heavy menstrual bleeding, pelvic pressure) * patients for whom surgery (hysterectomy or myomectomy) for the treatment of symptomatic uterine fibroids is planned * patients who are otherwise healthy as shown by medical history, physical and gynecological examinations, and laboratory test results exclusion criteria: * contraindications for the progesterone receptor modulators (prm) vilaprisan or ulipristal acetate * use of medication that might interfere with the conduct of the study or the interpretation of the results (e.g. continuing use of hormonal contraceptives, tranexamic acid or other treatments for heavy menstrual bleeding, progesterone receptor modulators, gonadotropin-releasing hormone agonist, anticoagulants, moderate and strong cyp3a4 inducers and moderate and strong cyp3a4 inhibitors within a defined time period before treatment starts.

Keywords: uterine fibroids bleeding reduction vilaprisan mode of action hysterectomy myomectomy pharmacodynamic